Tricuspid valve repair devices and associated systems and methods

Patent metadata

Field	Value
Publication number	US-12414855-B2
Application number	US-202117456153-A
Country	US
Kind code	B2
Filing date	Nov 22, 2021
Priority date	Nov 20, 2020
Publication date	Sep 16, 2025
Grant date	Sep 16, 2025

Abstract

Tricuspid valve repair devices and associated systems and methods are disclosed herein. A tricuspid valve repair device configured in accordance with embodiments of the present technology can include, for example, a coaptation member configured to be positioned between one or more native leaflets of the tricuspid valve to at least partially fill a space between the native leaflets. The tricuspid valve repair device can further include one or more fixation mechanisms for securing the coaptation member in position between the leaflets. The fixation mechanisms can include clip mechanisms, lock mechanisms, stabilization members, anchors, and/or other structures configured to engage cardiac anatomy local to or remote from the tricuspid valve, such as the native leaflets, the tricuspid valve annulus, the right ventricular outflow tract, the superior vena cava, the inferior vena cava, and so on.

First claim

We claim:

1. A tricuspid valve repair device, comprising:
a coaptation member configured to be positioned at least partially between a first native leaflet and a second native leaflet of a tricuspid valve;
a plurality of clip mechanisms coupled to the coaptation member, wherein each of the clip mechanisms is configured to clamp against a ventricular side of the first native leaflet to secure the first native leaflet between the clip mechanism and the coaptation member, and wherein the coaptation member includes a surface configured to coapt with at least the second native leaflet; and
a stabilization member extending from the coaptation member and configured to be positioned at least partially within a right atrium above the tricuspid valve, wherein the stabilization member is shaped to extend along and press against an atrial side of the first native leaflet and a wall within the right atrium above the first native leaflet to stabilize a position of the coaptation member relative to the tricuspid valve, and wherein the stabilization member is biased outwardly from the coaptation member to push a portion of the first native leaflet back from an opening of the tricuspid valve.

2. The tricuspid valve repair device of claim 1 wherein the first native leaflet is a native septal leaflet of the tricuspid valve.

3. The tricuspid valve repair device of claim 1 wherein the wall within the right atrium is a septal wall between the right atrium and a left atrium.

4. The tricuspid valve repair device of claim 1 wherein the first native leaflet is a native septal leaflet of the tricuspid valve, and wherein the wall within the right atrium is a septal wall between the right atrium and a left atrium.

5. The tricuspid valve repair device of claim 1 wherein the stabilization member includes a frame and a covering over the frame.

6. The tricuspid valve repair device of claim 5 wherein the frame is formed from a metal material, and wherein the covering is formed from at least one of a fabric material, an extruded polymeric material, and a graft material.

7. The tricuspid valve repair device of claim 5 wherein the frame has an M-like shape.

8. The tricuspid valve repair device of claim 5 wherein the frame includes two or more wireform loops extending from the coaptation member.

9. The tricuspid valve repair device of claim 1 wherein the coaptation member extends radially inward from the stabilization member toward a flow axis of the tricuspid valve, and wherein the stabilization member extends from the coaptation member at an angle relative to the flow axis.

10. The tricuspid valve repair device of claim 1 wherein the stabilization member includes an upper portion with a chevron-like shape.

11. The tricuspid valve repair device of claim 10 wherein the coaptation member includes an upper portion with a chevron-like shape.

12. The tricuspid valve repair device of claim 1 , further comprising a puncture member coupled to the stabilization member and configured to puncture the wall within the right atrium to further stabilize the position of the coaptation member relative to the tricuspid valve.

13. The tricuspid valve repair device of claim 1 wherein the stabilization member is shaped to extend along and press against the atrial side of the first native leaflet and the wall within the right atrium above the first native leaflet to substantially maintain the coaptation member in a substantially stationary position relative to the tricuspid valve during cardiac cycles.

14. The tricuspid valve repair device of claim 1 wherein the stabilization member comprises a frame made of stent material that provides lateral stiffness and torsional and front-to-back stability to reduce loads transferred to and/or from the coaptation member.

15. The tricuspid valve repair device of claim 1 wherein the stabilization member comprises a frame shaped to track a shape of and brace against the wall within the right atrium above a native valve annulus.

16. The tricuspid valve repair device of claim 1 wherein the stabilization member comprises a frame with an elongate shape extending away from the coaptation member and configured to be positioned above a native valve annulus.

17. The tricuspid valve repair device of claim 1 wherein the stabilization member comprises a frame configured to stabilize the position of the coaptation member relative to the tricuspid valve without penetrating cardiac tissue.

18. The tricuspid valve repair device of claim 1 wherein the stabilization member is angled from the coaptation member by an angle between 10-75 degrees.

19. A tricuspid valve repair device, comprising:
a coaptation member configured to be positioned at least partially between a native septal leaflet, a native posterior leaflet, and a native anterior leaflet of a tricuspid valve, wherein the coaptation member includes a first surface and a second surface;
multiple clip mechanisms coupled to the coaptation member, wherein each of the clip mechanisms is configured to move from an open state to a closed state, wherein—
in the open state, an arm member of the clip mechanism extends away from the coaptation member to allow a free end portion of the arm member to extend behind the native septal leaflet,
in the closed state, the arm member presses against a ventricular side of the native septal leaflet and the first surface of the coaptation member to secure the native septal leaflet between the clip mechanism and the first surface of the coaptation member, and
the second surface of the coaptation member is configured to coapt with at least one of the native anterior leaflet and the native posterior leaflet; and

a stabilization member extending from the coaptation member and configured to be positioned at least partially within a right atrium above the tricuspid valve, wherein the stabilization member is shaped to extend along and press against an atrial side of the native septal leaflet and a septal wall between the right atrium and a left atrium to (a) stabilize a position of the coaptation member relative to the tricuspid valve and (b) provide a platform for tissue ingrowth and long-term fixation, and wherein the stabilization member is biased outwardly from the coaptation member to push a portion of the native septal leaflet back from an opening of the tricuspid valve.

20. The tricuspid valve repair device of claim 19 wherein the tricuspid valve includes a flow axis, and wherein the stabilization member extends away from the coaptation member toward the septal wall at an angle relative to the flow axis.

21. The tricuspid valve repair device of claim 19 wherein the stabilization member includes a wireform extending from the coaptation member and a covering over the wireform.

22. The tricuspid valve repair device of claim 19 wherein the stabilization member is shaped to extend along and press against the atrial side of the native septal leaflet and the septal wall between the right atrium and the left atrium to substantially maintain the coaptation member in a substantially stationary position relative to the tricuspid valve during cardiac cycles.

23. A method of repairing a tricuspid valve, the method comprising:
deploying a coaptation member of a tricuspid valve repair device at least partially between a first native leaflet and a second native leaflet of a tricuspid valve;
grasping a first portion of a ventricular side of the first native leaflet with a first clip mechanism of the tricuspid va

Assignees

• Half Moon Medical Inc
• Medtronic Inc

Inventors

• Miyashiro Katherine
• Gifford Hanson S
• Fann James I
• Brian Ben F
• Krishnamurthy Gaurav
• Gonzalez Jose
• Gunning Paul
• Mclean Matthew
• Zimmerman Neil
• O'Grady Robert
• Sutton Douglas S
• Stringer Steven K

Classifications

• A61F2230/0056

  W-shaped, e.g. M-shaped, sigma-shaped · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/246 Primary

  Devices for obstructing a leak through a native valve in a closed condition · CPC title